BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 11964002 · Received June 9, 2021

    Report

    Report Number
    3010606081-2021-00015
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 9, 2021
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON MAY 12TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT THERE WERE TWO INCIDENTS IN THE PAST WEEK WHERE HE OVER-MEDICATED DUE TO HIGH BG READINGS. THE USER REPORTED THAT ON MAY 6TH HE RECEIVED READINGS RANGING FROM 157 MG/DL TO 212 MG/DL, WHICH HE MENTIONED WAS HIGH FOR HIM. DUE TO THESE ELEVATED READINGS, THE USER INCREASED HIS INSULIN FROM 14 TO 22 UNITS. THE USER REPORTED TODAY THAT HE TESTED HIS BG LEVEL TWICE IN THE MIDDLE OF THE DAY AND RECEIVED READINGS OF 172 MG/DL AND 199 MG/DL COMPARED TO TWO BG READINGS OF 120 MG/DL ON HIS NON-DARIO METER. DUE TO THESE ELEVATED READINGS, THE USER INCREASED HIS INSULIN AGAIN FROM 14 TO 22 UNITS. THE USER REPORTED THAT THE ABOVE MENTIONED MEDICATION INCREASES HAD NO NEGATIVE EFFECT ON HIM. WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER HAD BEEN USING ALCOHOL BEFORE TESTING HIS BG LEVELS. DARIO'S USER GUIDE, STATES IN THE SECTION REGARDING "FACTORS THAT INTERFERE WITH BLOOD GLUCOSE TESTING", THAT "ALCOHOL CAN AFFECT TEST RESULTS". IT WAS ALSO DETERMINED THAT THE USER DID NOT USE THE TEST STRIP WITHIN 3 MINUTES OF REMOVING IT FROM THE CARTRIDGE. DARIO'S USER GUIDE, STATES IN THE SECTION REGARDING "CAUSES OF UNEXPECTED RESULTS", "WAS THE BLOOD SAMPLE APPLIED TO THE TEST STRIP WITHIN 3 MINUTES OF REMOVING IT FROM THE CARTRIDGE?" A REPLACEMENT OF DARIO'S METER, CARTRIDGE OF STRIPS, AND CONTROL SOLUTION WERE SENT TO THE USER TOGETHER WITH A RETURN MATERIAL AUTHORIZATION (RMA) PACKAGE, TO FURTHER INVESTIGATE THIS ISSUE. AFTER THE ABOVE WAS RECEIVED, DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER AND HE REPORTED THAT HE RECEIVED A BG READING OF 132 MG/DL ON HIS NEW DARIO METER COMPARED TO A READING OF 130 MG/DL ON HIS NON-DARIO METER. THE USER DID NOT WISH TO PERFORM A CONTROL SOLUTION TEST WITH DARIO'S REPRESENTATIVE, AND REPORTED THAT HE WAS SATISFIED WITH THE BG READING THAT HE RECEIVED. AS OF THIS DATE, THE RMA WAS NOT RECEIVED. IF THE RMA IS RECEIVED AT A LATER DATE, A FOLLOW UP REPORT WILL BE SUBMITTED. THERE IS NOT ENOUGH INFORMATION AVAILABLE REGARDING THE DARIO METER AND STRIPS TO INVESTIGATE. NO RESOLUTION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861127 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other